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The Simplant® Digital Guide is a surgical guide intended for use in assisting in the placement of dental implants. The Simplant® Digital Guide is designed centrally by the Simplant® planning software and manufactured locally using Formlabs Dental SG resin, Locite 4304 adhesive, and Formlabs equipment: Form 2 printer, FormWash and FormCure washing and post-curing equipment.

The Simplant® Digital Guide is intended for use in assisting placement of dental implants. The subject Simplant® Digital Guide is a patient specific surgical template, which is designed according to the digital pre-operative plan of the dental implant positions. The clinician, or dental lab, orders a digital design file of the surgical quide (i.e. Simplant® Guide File) which is developed under the same process that is utilized to produce the design of the predicate Simplant® Guide (K170849). The subject Simplant® Digital Guide is then fabricated locally by the clinician or dental lab, utilizing stereolithography fabrication method. The subject Simplant® Digital Guide is intended to be fabricated using Dental SG acrylic resin, Form 2 SLA 3D printer, and FormWash and FormCure washing and post-curing equipment manufactured by Formlabs, Inc. The Simplant® Digital Guide sits on the patient's oral anatomy, i.e. teeth, mucosa or combination thereof. Aided by the Simplant® Digital Guide, the implant sites can be prepared, and the dental implants can be placed in the predetermined locations according to the previously pre-operative dental implant treatment plan.

CEREC Guides are intended to support the dentist or oral surgeon when drilling for placement of dental implants. CEREC Guides are intended to be designed and fabricated using the Sirona Dental CAD/CAM System's CEREC Chairside software and CAM equipment, Galileos Implant dental implant planning software, and Calibra Universal Self-Adhesive Resin Cement.

The CEREC Guide dental surgical guides are milled poly(methyl methacrylate) [PMMA] devices which are designed and fabricated utilizing the Sirona Dental CAD/CAM System with CEREC Chairside Software (K181520) and are intended to act only as dental implant placement templates. The CEREC Guides are designed in the Sirona Dental CAD/CAM System's CEREC Chairside Software utilizing, as an input, a completed dental implant treatment plan which is developed in the "Galileos Implant treatment planning software as cleared under premarket notification K093090. The CEREC Guide surgical guides are offered in two variants, the CEREC Guide 2 and CEREC Guide 3. Both the CEREC Guide 2 and CEREC Guide 3 are milled from the CEREC Guide Bloc milling blocks. The CEREC Guide Blocs are clear, PMMA blocks intended for milling utilizing the CEREC MC XL family of milling units. CEREC Guide Blocs are offered in two size variants, "medi" and "maxi". The CEREC Guide 2 surgical guides consist of the surgical guide body milled from the CEREC Guide Bloc PMMA milling blocks. The CEREC Guide 2 surgical guides are used in conjunction with CEREC Guide Drill Keys. CEREC Guide Drill Keys are stainless steel, reusable drill guide instruments which are offered in variants with internal diameters ranging from 2.0 mm to 4.85 mm. The CEREC Guide 3 surgical guides consist of the CAD/CAM surgical guide body milled from the CEREC Guide Bloc PMMA milling blocks. CEREC Guide 3 surgical guides feature integral titanium guide sleeves that are bonded the CEREC Guide 3 surgical guide body using Dentsply Sirona Calibra® Universal adhesive (K073173). The CEREC Guide 3 Guide Sleeves are single use and are offered in 4 size variants, with outer diameters ranging from 5.5 mm to 6.0 mm, and internal diameters ranging from 4.48 mm - 5.2 mm.

The SIMPLANT® Guide is intended for use in assisting placement of dental implants.

The SIMPLANT® Guide is intended for use in assisting placement of dental implants. It is a patient specific surgical template that is produced based upon knowledge of the location and orientation of the implant(s) prior to the surgery. The design of the SIMPLANT® Guide is made according to the clinician's plan of the implant positions. The final guide is fabricated from an epoxy resin using computerassisted manufacturing to produce a patient specific device. The SIMPLANT® Guide sits on the patient's oral anatomy, i.e. teeth, mucosa, bone or a combination thereof. Aided by the SIMPLANT® Guide, the implant sites can be prepared and the dental implants placed in the predetermined locations.

SPI® VECTOdrill™ Ceramic Drills are for use in the preparation of the implant site for all SPI® System implants.

SPI® VECTOdrill™ ceramic drills are reusable zirconia dental implant drill bits for use with the SPI Dental Implant System. SPI VECTOdrill ceramic drills include a pilot drill and three progressive twist drills. The pilot drill has a sler, highly efficient tip that initiates the pilot hole without the need for a round bur. The pilot drill also has the ability to cut laterally, in order to allow slight axial correction. The twist drills do not cut laterally, which helps to avoid enlarging the diameter of the osteotomy site. Each twist drill has an integrated guide at the tip, which is the same diameter as the preceding drill, in order to provide automatic axial quidance. The pilot drill has a diameter of 2.0 mm and is available in 29.0 mm and 34.0 mm lengths. The twist drill is available in three diameters (2.8 mm, 3.5 mm and 4.3 mm) and two lengths for each diameter (29.0 mm and 34.0 mm). Both the pilot drill and the twist drill have the proximal end configured to fit into a dental handpiece latch. All SPI VECTOdrills have a length 0.5 mm longer than the corresponding SPI Dental Implants. Each drill has depth markings that correspond to the VECTOdrill depth gauge in increments of 1.5 mm, from 8.0 mm to 17.0 mm. SPI VECTOdrill ceramic drills are intended to be resterilized and reused up to 20 times. SPI VECTOdrill ceramic drills are made of alumina toughened zirconia (ATZ). SPI VECTOdrill ceramic drills are packed individually in a transparent plastic tube contained in a sealed plastic sleeve and are provided non-sterile. Testing of SPI VECTOdrill ceramic drills established their ability to retain their cutting ability under aggressive cutting conditions. Testing also resulted in the conclusion that the mechanical properties of SPI VECTOdrill ceramic drills are appropriate for their safe use.